A Phase IV Clinical Study to Evaluate the Safety and Efficacy of ComVac5 (DTwP-Hep-B-Hib, Liquid Pentavalent vaccine of Bharat Biotech)

Phase 4

Completed

Registration Number: CTRI/2010/091/001128

Lead Sponsor: Bharat Biotech International Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 300

Inclusion Criteria

1)Parent/guardian of subject willing to give written informed consent and to comply to all study related procedures and visits.

2)Healthy male or female infant aged 6 to 8 weeks at the time of screening/enrollment.

3)Subjects who are healthy without any history of DTP and Hib vaccination. (As Hepatitis B vaccination is often done at birth, history of immunization against Hepatitis B at birth is not a parameter for exclusion but the fact is recorded in the case record form).

4)Infant who is HBsAg negative.

5)Subjects should have been born after 36-week term and are not less than 3200 gms, at the time of inclusion.

Exclusion Criteria

1)Fever of any origin of duration more than 3 days prior to/at screening visit.

2)Past history of DTP & Hib vaccination.

3)History of acute or chronic auto immune disease.

4)Any confirmed or suspected immunosuppressive condition.

5)Any treatment with immunosuppressive or immuno stimulant therapy

6)Use of any marketed or investigational or herbal medicine or non-registered drug or vaccine for DTP Hepatitis B and Hib.

7)Any criteria, which in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.

8)Known hypersensivity reactions to any of the components of the vaccine.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and immunogenicity of ComVac-5 (DTwP-Hep-B-Hib, Liquid Pentavalent vaccine of BBIL) Versus reference WHO Pre-Qualified vaccine, in healthy subjects of age 6-8 weeks at time of enrollment as a non-inferiority trial. <br/ ><br> <br/ ><br>Immunogenicity <br/ ><br>Seroconversion <br/ ><br>Seroprotection <br/ ><br>Timepoint: 3 months

Secondary Outcome Measures

Name	Time	Method
1. Safety: monitoring of all local and systemic Adverse Events (solicited and unsolicited) following vaccination throughout the study period of 3 months. <br/ ><br>2. To demonstrate lot to lot consistency between three different batch of test vaccine <br/ ><br>Timepoint: Throughout the study period.